Kornimate/medical-research-clean huggingface dataset:
prospective study measuring clinical outcomes of knee arthroplasty using the verasense™ knee system

Conditions: Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Post-traumatic Arthritis

Summary: the primary objectives of this evaluation are: 1) to attempt to refine the current clinical understanding of "balance" 2) to determine if patients with quantifiably balanced knee joints exhibit improved clinical outcomes versus patient with residual imbalance, as measured by the verasense™ knee system secondary objectives: * determine whether a difference in inter-compartment loads and soft tissue tension exists between the physicians intra-operative feel compared to the quantifiable data measured by the verasense™ knee system * determine which ligament releases are performed by the surgeon to improve soft tissue balance while utilizing the information from the verasense™ knee system * evaluate range of motion, pain, physical function, activity level, and patient satisfaction between baseline (pre-operative) and post-operative follow-up as well as radiographic success and survivorship of the knee implants


Eligibility criteria:
inclusion criteria: * subject must be a candidate for a primary total knee replacement * subject must be diagnosed with one or more of the following conditions: osteoarthritis, avascular necrosis, rheumatoid or other inflammatory arthritis post-traumatic arthritis * subject's joint must be anatomically and functionally suited to receive the selected implant * subject is 50 years of age or older (≥ 50 yrs) at the time of consent * subject is likely to be available for all study visits * subject is able and willing to sign the informed consent and follow study procedures * subject is not pregnant exclusion criteria: * prior total knee arthroplasty * subject has a mental condition that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the subject's cognitive abilities, senile dementia, and alzheimer's disease) * subject is pregnant * subject has an active infection or joint sepsis * subject has muscular, neurological or vascular deficiencies which compromise the affected extremity (i.e., parkinson's disease, multiple sclerosis, and charcot joints) * ligament insufficiencies, prior surgeries such as acl or pcl reconstructions, posterolateral reconstructions, osteotomies, tibia plateau fractures * range of motion less than 90 degrees, flexion contracture of more than 20 degrees

Keywords: ligament balance, total knee arthroplasty, intra-operative sensors
supraflex cruz pmcf study ( repic05 )

Conditions: Coronary Artery Disease (CAD); Ischemic Heart Disease

Summary: multicenter, prospective, non-randomized, post-market clinical follow-up (pmcf) study to confirm and support the clinical safety and performance of medical device regulations (mdr) with multivessel coronary disease requirements in all the consecutive patients treated with (supraflex cruz).

the objective of this multicenter, prospective, non-randomized, post-market clinical follow-up (pmcf) study is to confirm and support the clinical safety and performance of the supraflex cruz in a non-selected, real world population under daily clinical practice when used as intended by the manufacturer to meet eu medical device regulation requirements for post-market clinical follow-up.

Eligibility criteria:
inclusion criteria: * ≥ 18 years old and; * patients treated with supraflex cruz according to routine hospital practice and following instructions for use * patients with multivessel coronary artery disease (understood as that which affects more than one territory of the major epicardial coronary arteries - anterior descending, circumflex, right coronary artery) who is treated with more than 1 stent under study in lesions located in more than 1 of the aforementioned arteries. * substudy: patients with ejection fraction \<45% by echocardiography * informed consent signed exclusion criteria: * not meet inclusion criteria * contraindication for antiplatelet treatment * patient life expectancy less than 12 months

Keywords: ce-mdr (medical device regulations) pmcf (post-market clinical follow-up)
transcatheter closure versus surgery of perimembranous ventricular septal defects

Conditions: Ventricular Septal Defects

Summary: the purpose of this study is to investigate effectiveness and safety of transcatheter closure of perimembranous ventricular septal defects.

perimembranous ventricular septal defect (vsd) is the most common congenital cardiac malformation and constitutes over 20% of all congenital cardiac disease. though conventional surgery for vsd is a widely accepted procedure with minimal operative mortality, it carries a small but definite risk of morbidity and mortality associated with cardiopulmonary bypass and surgical closure. the newly appeared transcatheter device closure technique provides an alternative to surgical closure. however, the mid-to-long term effects of this technique using occluders is not clear. the aim of this study was to evaluate the safety and effectiveness of transcatheter closure of perimembranous ventricular septal defects using septal occluders.

Eligibility criteria:
inclusion criteria: * patients with ventricular septal defects eligible for transcatheter closure. exclusion criteria: * patients less than 2 years old. patients not suitable for transcatheter closure. patients comorbid with other diseases.

Keywords: transcatheter closure ventricular septal defects
a study to see if gsk256073a can block niacin-induced flushing in healthy volunteers

Conditions: Healthy Subjects; Dyslipidaemias

Summary: to test the ability of gsk256073 to block niacin-induced flushing when gsk256073 and niacin are co-administered as single doses to hvts.


Eligibility criteria:
inclusion criteria: * adult males between 18 and 55 years of age, inclusive. * healthy subjects * body weight \> 50 kg (110 pounds) and body mass index (bmi) between 19 and 31 where: * subjects with qtc \< 450 msec at screening exclusion criteria: * history of significant cardiac arrhythmias * active peptic ulcer disease (pud) and/or history of pud * history of gout and/or hyperuricemia * history of gilbert's syndrome * history of recurrent indigestion, stomach upset or diarrhea * history of other than rare (once yearly or less) flushing * recurrent skin rash or psoriasis * history of kidney stones

Keywords: flushing gsk256073a, dose escalation, immediate release niacin,
sensory optimization of the hospital environment

Conditions: Preterm; Parent-Child Relations; Parents; Development, Infant; Sensory Integration Dysfunction

Summary: the long-term goal of this project is to improve the health and well-being of preterm infants and their parents. although there is evidence to support positive multisensory interventions in the nicu, these interventions are often applied in an inconsistent manner, reducing their benefit. through a rigorous and scientific process, we have developed a structured multisensory intervention program, titled supporting and enhancing nicu sensory experiences (sense), which includes specific doses and targeted timing of evidence-based interventions such as massage, auditory exposure, rocking, holding, and skin-to-skin care. the interventions are based on the infant's developmental stage and are adapted based on the infant's medical status and behavioral cues. the multisensory interventions are designed to be conducted during each day of nicu hospitalization by the parents, who are educated and supported to provide them. the proposed work aims to determine the effect of multisensory interventions on parent mental health, parent-child interaction, brain activity (amplitude integrated electroencephalography), and infant developmental outcomes through age 2 years, with specific attention to language outcome.

two-hundred fifteen parent-infant dyads of preterm infants born ≤ 32 weeks gestation and admitted to a level iv nicu (and associated level iii nicu) will be enrolled within 1 week of birth. infants will be randomized to either the sense multisensory program or to the standard of care during the nicu stay. the sense program combines structured, easy-to-conduct, multisensory interventions with parent engagement to optimize outcomes in the complex medical environment of the nicu. standardized assessments of parent mental health, infant neurodevelopment, and parent-child interaction will be conducted prior to nicu discharge and at 6 months, 1 year, and 2 years, adjusted for prematurity. differences between groups will be investigated. brain activity during nicu stay, including in the presence and absence of different sensory exposures, will also be investigated. the expected outcome is that the sense multisensory program will have a positive effect on improving outcomes.

Eligibility criteria:
inclusion criteria: * ≤ 32 weeks estimated gestational age (ega) * recruited within the first week of life exclusion criteria: * \> 32 weeks ega at birth * \>7 days old * become wards of the state * have a suspected or confirmed congenital anomaly * face a high immediate threat of death, per the opinion of the attending physician.
interprofessional preoperative geriatric assessment for older arthroplasty patients with multimorbidity

Conditions: Multimorbidity; Knee Arthrosis; Hip Arthrosis

Summary: the objective of this randomized control trial is to investigate effects and cost effectiveness of interprofessional preoperative assessment among older knee or hip arthroplasty patients. the main hypothesis is that preoperative assessment and optimization have a positive impact on the patents' quality of life and expenditure of social and health care services.

knee and hip arthrosis are common conditions among older adults. progression of arthrosis often leads to worsening of symptoms and decreased mobility, daily functioning and quality of life. total joint arthroplasty improves pain in end-stage arthrosis but accustomed postoperative care and rehabilitation alone may not guarantee optimal regain of functioning for frail and vulnerable older arthroplasty patients. preoperative optimization of older patients with multimorbidity and functional limitations may improve benefits of the arthroplasty even at lower costs. patients randomized into intervention arm of the present study receive preoperative assessment with treatment and prehabilitation plan. the focuses of the intervention are patient's chronic conditions, nutritional status, medication and physical activity. the intervention is delivered by multiprofessional team (geriatrician, registered nurse, physiotherapist and pharmacist). older adults undergoing surgery are a rapidly growing but vulnerable patient group. knowledge on effects of preoperative evaluation and optimization is sparse, especially on the effects of multi-domain interventions.

Eligibility criteria:
inclusion criteria: * place of residence: kuopio or vesanto municipality * age ≥ 65 years * clinical decision for knee or hip arthroplasty, elective operation with more than one month waiting time, primary arthroplasty of the index joint. * multimorbidity: the patient has at least two chronic diseases with potential to affect functioning, diseases are defined according to the function comorbidity index (fci) additional inclusion criteria, at least two of the following: * 5 or more medicines taken regularly (polypharmacy) * continuous walking distance less than 500 m * needs help in dressing and/or washing oneself * needs help when visiting or taking care of businesses outside home * body mass index ≤ 23 or ≥ 34 exclusion criteria: - does not meet the above inclusion criteria

Keywords: preoperative geriatric assessment interprofessional team
xray volume imaging (cone beam ct) - prostate cancer

Conditions: Prostatic Neoplasms

Summary: conformal dose escalated radiotherapy was adopted as the standard treatment technique at pmh for intermediate risk patients with localised disease in 1997. this technique provides a much smaller margin of error for treatment set-up and delivery than with conventional techniques. one way to ensure the accuracy of treatment delivery is to image the prostate position daily, prior to therapy, to allow for appropriate set-up corrections. to do so, imaging markers are implanted into the prostate under guided ultrasound (a standard procedure at pmh). however, there are disadvantages in using imaging markers which include added time to the treatment planning process, and an invasive procedure with a potential for discomfort, bleeding and infection. this study will investigate and compare x-ray volume imaging to the gold standard imaging markers.


Eligibility criteria:
inclusion criteria: * diagnosis of adenocarcinoma of the prostate * patient undergoing escalated dose conformal external beam radiotherapy. * patient has low or intermediate risk prognostic factors: all of psa \<21, gleason score \<8, clinical t category \<t3, clinical n category 0 or x, m category 0 or x. * informed consent exclusion criteria: * no diagnosis of adenocarcinoma of the prostate * patient not undergoing escalated dose conformal radiotherapy * patient does not have low or intermediate risk prognostic factors
safety and efficacy of ain457 in noninfectious uveitis

Conditions: Non-infectious Uveitis

Summary: this study was performed to evaluate the efficacy and safety of ain457 for patients with active uveitis that requires systemic immunosuppression.


Eligibility criteria:
inclusion criteria: * active uveitis (i.e., uveitis that is not in remission). * intermediate uveitis, posterior uveitis, or panuveitis must be sufficiently severe that systemic immunosuppression is indicated. exclusion criteria: * active infection. * weight must not be greater that 120kg. other protocol-defined inclusion/exclusion criteria may apply

Keywords: uveitis eye il-17 il-17a il17 ain457 vogt-koyanagi-harada behcet's behcet sympathetic ophthalmia multifocal choroiditis birdshot hla-b27 birdshot retinochoroiditis retinal vasculitis sarcoidosis intermediate uveitis panuveitis posterior uveitis
a patient-centered intervention to improve opioid safety

Conditions: Opioid Safety; Prescription Opioid Misuse; Chronic Pain

Summary: this is a randomized controlled trial of a multifaceted intervention designed to improve the safety of opioid prescribing. the specific aims of this study are to: (a) evaluate whether a multifaceted intervention (improving the safety of opioid prescribing; isop) enhances opioid safety, (b) assess whether participation in isop impacts the clinician-patient relationship, and (c) explore to what extent isop is associated with changes in pain and pain-related function.

the investigators will randomize primary care providers (pcps) at the va portland health care system to either isop or the control condition; patients will be nested by clinician status. all pcps who enroll will participate in either a two-hour educational workshop or the two-hour educational workshop + nurse care manager (ncm). the ncm will maintain a registry of enrolled patients, track opioid medication-related events from the medical record, and provide decision support to pcps for issues related to prescription opioid safety. the ncm will also meet individually with enrolled participants to discuss strategies for preventing/reducing opioid side effects, preventing diversion, and providing rationale for screening for prescription opioid misuse. the investigators will recruit patients who are already prescribed chronic opioid therapy for chronic non-cancer pain. participants will be enrolled for one year. outcomes will be measured at baseline, and 6 and 12 months after enrollment.

Eligibility criteria:
inclusion criteria: * enrollment in primary care at the va portland health care system * receiving long-term opioid therapy (for at least 3 months) for chronic pain unrelated to a life-limiting disease * able to read and write in english exclusion criteria: * age younger than 18 years old * on opioid therapy for palliative or end-of-life care * current enrollment in an opioid substitution program * lack of access to a telephone

Keywords: opioid safety opioid misuse opioid abuse patient-centered opioid opiate chronic pain primary care veteran clinical care
insoles effect on pain and daily activities

Conditions: Non-specific Pain in Lower Extremities

Summary: the aims of this study were to evaluate the effects of insoles on pain, daily activities and physical activity level, and to investigate the relation between satisfaction with the insoles and their actual use in individuals with le pain.

pain in weight-bearing joints limits individual's function and ability to perform daily activities, causes a negative effect on productivity and increased costs for social insurance. this pain is often the outcome of structural deformities or work-related foot pain often occurs in workers whose occupations include standing or walking for a long time. one of the most common reasons for prescribing insoles is to enhance functioning by reducing nonspecific pain in the foot, leg or low back pain. reduction of pain is expected to improve quality of life in daily activities such as work and recreational activities. persons actual use of the insoles, is a prerequisite for any effect it may have. it can be hypothesized that the use of the insoles is related to what the user thinks about their comfort, appearance, the amount of foot perspiration they induce, and other factors.

Eligibility criteria:
inclusion criteria: * pain in lower extremities * aged 18 years or older * able to speak swedish. exclusion criteria: * pain due to a systemic or progressive disease * use of orthosis of other type than insoles * earlier foot surgery or current use of prosthesis.

Keywords: orthotic devices activities of daily living pain measurement lower extremity foot personal satisfaction
mobile app for latinx hazardous drinkers with clinical anxiety

Conditions: Alcohol Abuse; Anxiety

Summary: the purpose of this study is to develop and examine a culturally adapted, brief, integrated, spanish language mobile health application for the android platform, optimized to deliver a personalized feedback intervention (pfi) designed to enhance knowledge regarding adverse anxiety-alcohol interrelations, increase motivation and intention to reduce hazardous drinking, and reduce positive attitudes and intention regarding anxiety-related alcohol use among latinx hazardous drinkers with clinical anxiety.

investigators will develop a culturally adapted, brief, single-session, spanish language, pfi delivered via a mobile health application for the android platform through an iterative approach using expert input and focus groups. next, latinx hazardous drinkers with clinical anxiety will assess program navigation and conduct usability testing. finally, latinx hazardous drinkers with clinical anxiety will be recruited to complete the final prototype of the mobile health application in order to evaluate the feasibility, acceptability, and initial effects. initial screening will be conducted via telephone; baseline and post-treatment data will be collected in-person; and 1-week, 1-month, and 3-months follow-up data will be collected remotely.

Eligibility criteria:
inclusion criteria: * 21 years of age or older * self-identified as latinx or hispanic * fluent in spanish * current hazardous drinking pattern * current clinical anxiety * able to provide written, informed consent * owning an android smartphone exclusion criteria: * currently involved in alcohol or other substance use program * concurrent use of medication for anxiety or depression * current engagement in psychotherapy for anxiety or depression

Keywords: latinx hispanic personalized feedback intervention
simple, mobile-based artificial intelligence algorithms in the detection of diabetic retinopathy (smart) study

Conditions: Diabetic Retinopathy

Summary: this is an observational cross sectional study aimed to evaluate the performance of the artificial intelligence algorithm in detecting any grade of diabetic retinopathy using retinal images from patients with diabetes.


Eligibility criteria:
inclusion criteria: 1. patients with type 1 or type 2 diabetes mellitus 2. ages 18 and above 3. male and female exclusion criteria: 1. persistent visual impairment in one or both eyes; 2. subjects with corneal opacities and advanced cataract. 3. history of retinal vascular (vein or artery) occlusion; 4. subject is contraindicated for fundus photography (for example, has light sensitivity); 5. subject is currently enrolled in an interventional study of an investigational device or drug; 6. subject has a condition or is in a situation which in the opinion of the investigator, might confound study results, may interfere significantly with the subject's participation in the study, or may result in ungradable clinical reference standard photographs.
a research about nutrition impact for local advanced nasopharyngeal carcinoma patients

Conditions: Malignant Neoplasm of Nasopharynx

Summary: the chemo-radiotherapy for the local advanced nasopharyngeal carcinoma patients will induce the mucosal ulcer and damage salivary glands. consequently, it can disturb the nutrition conditions and clinical outcomes of patients. this research tries to evaluate the nutrition status at the baseline, before and after radiotherapy, during the follow-up by the body mass index, hematological indexes, immunological indexes, and nutrition questionnaires including pg-sga and nrs 2002. through the evaluation of two different nutritional interventions, the investigators aim to find an optimized assessment model and the best nutrition support patterns.

all nasopharyngeal patients received radical treatment including neo-adjuvant chemotherapy and concurrent chemo-radiotherapy. at the beginning, the investigators assign patient to experimental and control groups randomly. patients in experimental group received standard nutritional support by adding nutrison. control patients will give conventional nutritional guidance. the investigators collected all the nutritional indexed at first visit, before and after radiotherapy, 1, 3, 6, 9, 12 months after radiotherapy. all these data will be set into statistical software to produce an optimized model for clinical practice.

Eligibility criteria:
inclusion criteria: 1. histologically conformed initial nasopharyngeal carcinoma 2. patients can feed through the mouth. 3. ecog (eastern cooperative oncology group) : 0-2. 4. no history of chemo-radiotherapy, immuno-therapy or biotherapy. 5. normal hemodynamic indices before the recruitment (including white blood cell count\>4.0×109/l, neutrophil count\>1.5×109/l, platelet count \>100×109/l, hemoglobin≥90g/l, normal liver/kidney function). 6. informed consent signed. exclusion criteria: 1. history of malignant tumors. 2. any severe complications contraindicated chemotherapy or radiotherapy. 3. medical history of central nervous system, cognitive or psychological diseases; 4. pregnant or nursing women. 5. patients with mental disease cannot complete the questionaire. 6. patients refused the informed consent.

Keywords: nasopharyngeal carcinoma intensity-modulated radiotherapy nutrition support nutrition assessment